Regulatory Affairs Specialist

Are you an experienced Regulatory Affairs specialist or Medical Writer? Do you have experience in the writing / authoring of technical files? If so, we would love to speak with you!

We are recruiting for a Regulatory Affairs Specialist to join our clients Infectious Disease business unit, preparing documentation for international product registrations.

We are looking for someone with an RA or Medical Writing background, preferably within an IVD or medical device manufacturing environment.

This role is fully remote within the UK, Inside IR35 and contracted initially until the end of 2025 working 37.5 hours per week.

Responsibilities:

• Responsible for technical writing of files in accordance with In Vitro Diagnostic medical device Regulation (IVDR).
• Provides regulatory support for diagnostic product development and commercial diagnostic products.
• Performs regulatory impact assessments.
• Coordinate with internal and external stakeholders to gather necessary information.
• Develops regulatory strategies for products in development and for modified products to achieve clearance/approval internationally.
• Provides regulatory support to regional regulatory teams to assist with submissions, license renewals, and license amendments.
• Compiles and publishes all material required for submissions, license renewals, and annual registrations.
• Maintains approvals/licenses/authorizations for existing marketing authorizations.
• Assesses product, manufacturing, and labeling changes for regulatory reporting impact and compliance to regulations.
• Organizes and maintains hard copy and electronic department files.
• Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies.

Education and experience:

• Bachelor's Degree in Biology, Chemistry, Biochemistry, Engineering or other related technical field or the equivalent combination of education and experience.
• Previous experience in Regulatory Affairs or Medical Writing.
• Strong knowledge of IVDR, EU and international regulatory requirements is preferred.
• Demonstrated written and verbal communication skills.
• Strong time management skills, with the ability to work on multiple projects simultaneously.
• Ability to work independently as well as within a team.
• Proficiency with Microsoft Office, including Word, Excel, PowerPoint and Visio.

Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.

Candidates must be eligible to live and work in the UK.

For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.